Further reading material:
Rieder HL et al. The public health service national tuberculosis reference laboratory and the national laboratory network. Minimum requirements, role and operation in a low-income country. Paris, International Union Against Tuberculosis and Lung Disease, 1998.
Goal phase 1
To ensure that the primary process operates correctly and safely.
The primary process is the total process of laboratory testing, from pre-analytical (the sample is collected, registered and processed) to analytical (the actual laboratory test) to post-analytical (the result is recorded, the report is made and sent to the clinician).
In this phase the fundaments of a quality management system will be set up. The major activities include:
- Formation of a quality project team.
- Updating of background knowledge on quality management (i.e. through courses for both staff and management).
- Development of Standard Operation Procedures for the laboratory tests to assure that TB testing is performed in a standardized manner, according to a defined methodology and with adequate respect for safety.
- Development of Standard Operation Procedures and a maintenance schedule for the laboratory equipment to assure proper and safe use of equipment.
- Upgrading of laboratory biosafety with appointment of a biosafety officer, biosafety training to all staff, biosafety assessment, and introduction of a biosafety manual.
NOTE: When certain steps in this phase cannot be completed yet due to external factors, but the remainder of the activities of phase 1 have been implemented, the laboratory may start with implementing phase 2 activities. Keep in mind that elements of phase 1 still need to be implemented.